East and the Independent Statistician: Answering the Toughest Development Questions

Since it was first introduced over twenty years ago, the predictive simulation technology in today’s East has come a long way.  Biotatistician Lukas Makris has come a long way, too, now an established Independent Consulting Statistician.  In this role, Lukas now helps primarily emerging biotechs and specialty developers determine their optimal early stage clinical strategy.

Biotech and specialty portfolio developers typically know their molecule or drug well, but are always seeking greater certainty on how the experimental agent will perform in the clinic.  They initially turn to Lukas to best answer the question: “What research strategy will provide the best opportunity to justify continued development?  And once underway: “Are we progressing accordingly or deviating from plan?”  Today’s East provides Lukas and his client sponsors with answers to these key questions. 

Fast Answers to "What if…?”

Lukas reports that sponsors often want answers to an array of “what if” scenarios: “What if the trial’s subject recruitment lags in the first 3 months, what would be the impact?  What could we expect if we increase the sample size to compensate?”  Their Investors want to better understand the risk and reward trade-offs to formulate the funding strategy.  In fact, Lukas has observed that the biotech investment community is often quite savvy about adaptive approaches.  They appreciate how simulating different scenarios enables quantitative decision-making supporting formulation of the optimal strategy.